Acetaminophen, Dextromethorphan HBr ,Guaifenesin 325 mg/1
Acetaminophen, Dextromethorphan HBr ,Guaifenesin · CAPSULE, LIQUID FILLED · Softgel Healthcare Pvt Ltd
Acetaminophen, Dextromethorphan HBr ,Guaifenesin is a prescription capsule, liquid filled containing acetaminophen, dextromethorphan hbr ,guaifenesin at 325 mg/1, taken oral. Manufactured by Softgel Healthcare Pvt Ltd.
Key Facts
- Brand Name
- Acetaminophen, Dextromethorphan HBr ,Guaifenesin
- Generic Name
- Acetaminophen, Dextromethorphan HBr ,Guaifenesin
- NDC Code (Product)
35916-0184- Manufacturer
- Softgel Healthcare Pvt Ltd
- Strength
- 325 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- HUMAN OTC DRUG
- Application #
- M012
- Drug Class
- Decreased Respiratory Secretion Viscosity [PE]; Expectorant [EPC]
- Marketing Start
- 05/17/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.
Dosage & Administration
Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use
Warnings
Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Frequently Asked Questions
What is Acetaminophen, Dextromethorphan HBr ,Guaifenesin used for?
Acetaminophen, Dextromethorphan HBr ,Guaifenesin contains Acetaminophen, Dextromethorphan HBr ,Guaifenesin. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.
Is Acetaminophen, Dextromethorphan HBr ,Guaifenesin a controlled substance?
Acetaminophen, Dextromethorphan HBr ,Guaifenesin is not classified as a controlled substance by the DEA.
What is the generic name for Acetaminophen, Dextromethorphan HBr ,Guaifenesin?
The generic name for Acetaminophen, Dextromethorphan HBr ,Guaifenesin is Acetaminophen, Dextromethorphan HBr ,Guaifenesin. There are no other listed brand versions of Acetaminophen, Dextromethorphan HBr ,Guaifenesin.
What is the NDC code for Acetaminophen, Dextromethorphan HBr ,Guaifenesin 325 mg/1?
The NDC (National Drug Code) for Acetaminophen, Dextromethorphan HBr ,Guaifenesin 325 mg/1 is 35916-0184, listed by Softgel Healthcare Pvt Ltd.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)